Trial Outcomes & Findings for Hypofractionated Radiotherapy in Breast Cancer (NCT NCT03167359)
NCT ID: NCT03167359
Last Updated: 2021-05-07
Results Overview
Cutaneous toxicity rate will be assessed by the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) v.3 grading scale. THe NCI CTCAE grades go from 0 to 4. Grade 0: none. Grade 1: Mild or localized; topical intervention indicated. Grade 2: Intense or widespread; intermittent; skin changes from scratching (e.g., edema, papulation, excoriations, lichenification, oozing/crusts); limiting instrumental ADLs. Grade 3-4: Severe or life-threatening. The higher the grade, the worse the outcome.
COMPLETED
NA
74 participants
Duration of Study (Up to 18 months)
2021-05-07
Participant Flow
Participant milestones
| Measure |
Participants With Stage 0-III Breast Cancer
Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.
Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
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|---|---|
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Overall Study
STARTED
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74
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Overall Study
COMPLETED
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72
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Participants With Stage 0-III Breast Cancer
Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.
Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
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|---|---|
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Overall Study
Physician Decision
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1
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
Hypofractionated Radiotherapy in Breast Cancer
Baseline characteristics by cohort
| Measure |
Participants With Stage 0-III Breast Cancer
n=74 Participants
Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.
Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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55 Participants
n=5 Participants
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Age, Categorical
>=65 years
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19 Participants
n=5 Participants
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Sex: Female, Male
Female
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74 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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3 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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29 Participants
n=5 Participants
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Race (NIH/OMB)
White
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39 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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3 Participants
n=5 Participants
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Region of Enrollment
United States
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74 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Duration of Study (Up to 18 months)Population: Data is missing on one participant who completed the study. Another patient developed a contralateral breast cancer during the study and another patient was lost to follow up. These latter two patients did not complete the 1 year post radiation assessment.
Cutaneous toxicity rate will be assessed by the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) v.3 grading scale. THe NCI CTCAE grades go from 0 to 4. Grade 0: none. Grade 1: Mild or localized; topical intervention indicated. Grade 2: Intense or widespread; intermittent; skin changes from scratching (e.g., edema, papulation, excoriations, lichenification, oozing/crusts); limiting instrumental ADLs. Grade 3-4: Severe or life-threatening. The higher the grade, the worse the outcome.
Outcome measures
| Measure |
Participants With Stage 0-III Breast Cancer
n=71 Participants
Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.
Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
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Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4)
Grade 0
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60 Participants
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Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4)
Grade 1
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11 Participants
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Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4)
Grade 2
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0 Participants
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Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4)
Grade 3
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0 Participants
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Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4)
Grade 4
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0 Participants
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PRIMARY outcome
Timeframe: Duration of Study (Up to 18 months)Population: 30 patients received regional nodal irradiation, and per protocol, this subcohort of patients were assessed for lymphedema and brachial plexopathy. Patients who did not receive regional nodal irradiation did not undergo assessments for brachial plexopathy or lymphedema.
Number of Participants with 20% or greater increase in arm lymphedema (compared to baseline arm measurements) will be assessed among breast cancer patients receiving regional nodal irradiation.
Outcome measures
| Measure |
Participants With Stage 0-III Breast Cancer
n=30 Participants
Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.
Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
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|---|---|
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Number of Participants With 20% or Greater Increase in Arm Lymphedema Compared to Baseline
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0 Participants
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PRIMARY outcome
Timeframe: Duration of Study (Up to 18 months)Population: Per protocol, only patients who received regional nodal irradiation were assessed for brachial plexopathy. 30 enrolled patients received regional nodal irradiation and then were assessed for brachial plexopath.
Number of Participants with Grade 3 Brachial Plexopathy will be assessed among breast cancer patients receiving regional nodal irradiation by RTOG and LENT/SOMA scales Brachial plexopathy range minimum 0 and maximum 4. The higher the score, the worse the outcome
Outcome measures
| Measure |
Participants With Stage 0-III Breast Cancer
n=30 Participants
Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.
Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
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|---|---|
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Number of Participants With Grade 3 Brachial Plexopathy
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0 Participants
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SECONDARY outcome
Timeframe: Baseline, end of Follow Up (Up to 18 months) (up to 18 months)Population: One patient did not complete her ultrasound measurements of skin toxicity.
Ultrasound tissue characterization (UTC) is driven by knowledge of the physics of ultrasound and its interactions with biological tissue, and has traditionally used signal modelling and analysis to characterize and differentiate between healthy and diseased tissue. Change in mean UTC at last assessment (up to 18 months post XRT) was compared to baseline (pre-XRT) measures.
Outcome measures
| Measure |
Participants With Stage 0-III Breast Cancer
n=71 Participants
Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.
Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
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|---|---|
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Change in Cutaneous Toxicity Rate Assessed by Ultrasound Tissue Characterizations (UTC)
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-0.91 percentage change in skin thickness
Standard Deviation 0.39262
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SECONDARY outcome
Timeframe: Baseline, Post Intervention (Up to 18 Months)Population: Specimens were not processed due to limited funds
Blood will be analyzed for TNF-alpha (TNF)-alpha levels and correlated to the development of cutaneous toxicity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Post Intervention (Up to 18 Months)Population: Specimens were not processed due to limited funds.
Blood will be analyzed for soluble TNF receptor 2 (sTNFR2) levels and correlated to the development of cutaneous toxicity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Post Intervention (Up to 18 Months)Population: Specimens were not processed due to limited funds
Blood will be analyzed for interleukin (IL)-6 levels and correlated to the development of cutaneous toxicity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Post Intervention (Up to 18 Months)Population: Specimens were not processed due to limited funds
Blood will be analyzed for IL-1ra levels and correlated to the development of cutaneous toxicity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Post Intervention (Up to 18 Months)Population: Specimens were not processed due to limited funds
Blood will be analyzed for CRP levels and correlated to the development of cutaneous toxicity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, end of Follow Up (Up to 18 months)The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report instrument designed to measure fatigue. Scores range from 20 to 100.The higher the score, the more fatigued. The higher the maximum change, the greater increase in fatigue a patient feels.
Outcome measures
| Measure |
Participants With Stage 0-III Breast Cancer
n=72 Participants
Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.
Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
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Change in Multidimensional Fatigue Inventory (MFI) Score
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-6.33 score on a scale
Standard Deviation 12.96
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SECONDARY outcome
Timeframe: Baseline, End of Follow Up (Up to 18 months)The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Scores range from 0 to 21. A score of less than or equal to 5 is associated with good sleep quality. A score greater than 5 is associated with poor sleep quality. The higher the maximum change, the greater increase in sleep disturbances a patient has.
Outcome measures
| Measure |
Participants With Stage 0-III Breast Cancer
n=72 Participants
Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.
Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
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|---|---|
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Change in Pittsburgh Sleep Quality Index (PSQI) Score
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-0.75 score on a scale
Standard Deviation 2.77
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SECONDARY outcome
Timeframe: Baseline, End of Follow Up (Up to 18 months)The PSS is a self-reported instrument used to measure the perception of stress. Scores range from 0 to 40. Score of 20 or higher are considered high stress. The higher the maximum change, the greater increase in stress the patient feels.
Outcome measures
| Measure |
Participants With Stage 0-III Breast Cancer
n=72 Participants
Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.
Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
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|---|---|
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Change in Perceived Stress Scale (PSS) Score
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-2.92 score on a scale
Standard Deviation 6.99
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SECONDARY outcome
Timeframe: Baseline, End of Follow Up (Up to 18 months)Population: Patient were asked to complete this instrument only after an amendment was made to the protocol. Therefore, the last 23 patients enrolled completed this survey due to the fact that it was added to the protocol in after the majority of patients had been enrolled on the study.
The PROMIS Fatigue questionnaire is a self-report tool used to evaluate frequency, duration, and intensity of fatigue over the past seven days. Scores range from 7 to 35. The higher the score, the more fatigue.
Outcome measures
| Measure |
Participants With Stage 0-III Breast Cancer
n=23 Participants
Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.
Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
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|---|---|
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Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score
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-2.57 score on a scale
Standard Deviation 6.82
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SECONDARY outcome
Timeframe: Baseline, End of Follow Up (Up to 18 months)The IDS-SR is a self-reported measure in which participants rate the frequency of depression symptoms within the past seven days. Scores range from 0 to 84, with higher score reflecting greater severity of depressive symptoms.
Outcome measures
| Measure |
Participants With Stage 0-III Breast Cancer
n=72 Participants
Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.
Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
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|---|---|
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Change in an Inventory of Depressive Symptomatology-Self Reported (IDS-SR) Score
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-3.21 score on a scale
Standard Deviation 8.81
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SECONDARY outcome
Timeframe: Baseline, End of Follow Up (Up to 18 months)The SF-36 is a self-reported survey of health status. Scores range from 0 to 100. Lower scores indicate disability. The higher the score, the less disability.
Outcome measures
| Measure |
Participants With Stage 0-III Breast Cancer
n=72 Participants
Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.
Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
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|---|---|
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Change in Short Form-36 (SF-36) Health Survey Score
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11.07 score on a scale
Standard Deviation 15.89
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SECONDARY outcome
Timeframe: Baseline, End of Follow Up (Up to 18 months)Population: This instrument was added to the protocol in an amendment and therefore the first two patients who were enrolled did not complete this instrument because they participated prior to approval of that amendment.
The GLTEQ is a self-reported questionnaire used to measure usual leisure-time exercise habits during a typical seven day period. The GLTEQ specifically inquires about frequency of mild, moderate, and strenuous physical activity done during a typical 7-day period with exercise of more than 15 min or more per day during the previous week. Total score for the Godin leisure-time exercise questionnaire is calculated using this formula.Weekly leisure activity score = (9 × Strenuous) + (5 × Moderate) + (3 × Light). The GLTEQ total score can be broken into three categories: less than 14 points = sedentary 14 - 23 points is = moderately active 24 points or more = active The score ranges from 0 to 119.
Outcome measures
| Measure |
Participants With Stage 0-III Breast Cancer
n=70 Participants
Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.
Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
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|---|---|
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Change in Godin Leisure-Time Exercise Questionnaire (GLTEQ) Score
|
5.21 score on a scale
Standard Deviation 21.55
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SECONDARY outcome
Timeframe: Baseline, End of Follow Up (Up to 18 months)Population: Per protocol, this questionnaire was administered only to patients who received regional nodal irradiation.
The Lent Soma questionnaire is a self-reported measure of pain. Scores range from 0 to 9. The higher the score, the more pain reported.The higher the maximum change, the more increase in breast pain, the patient is perceiving.
Outcome measures
| Measure |
Participants With Stage 0-III Breast Cancer
n=30 Participants
Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.
Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
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|---|---|
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Change in Lent Soma Scale Patient Questionnaire Score
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-1.12 score on a scale
Standard Deviation 2.59
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SECONDARY outcome
Timeframe: Baseline, End of Follow Up (Up to 18 months)Population: This instrument was added in an amendment to the protocol after a number of patients had already been enrolled. Once approved, patients who were enrolled then completed the instrument at the corresponding timepoints after the amendment was approved.
Participants will be asked to rate their breast pain level on a study specific scale from 0 to 10 where 0 represents no pain, and 10 represents the most extreme pain. The higher the maximum change, the more increase in breast pain, the patient is perceiving.
Outcome measures
| Measure |
Participants With Stage 0-III Breast Cancer
n=57 Participants
Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.
Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
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|---|---|
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Change in Breast Pain Level
|
0.26 score on a scale
Standard Deviation 2.51
|
SECONDARY outcome
Timeframe: Baseline, End of Follow Up (Up to 18 months)Population: This questionnaire was added in an amendment after the majority of patients were enrolled on study. Once the amendment was approved by Emory IRB, the questionnaire was administered to the remaining 33 patients.
Participants will be asked to rate the look of their breast on a study specific scale from 0 to 10 where 0 represents not happy, and 10 represents very happy. The higher the maximum change, the more increase in happiness with breast appearance the patient is reporting.
Outcome measures
| Measure |
Participants With Stage 0-III Breast Cancer
n=33 Participants
Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.
Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
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|---|---|
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Change in Breast Appearance Satisfaction Score
|
.30 score on a scale
Standard Deviation 2.62
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SECONDARY outcome
Timeframe: Baseline, End of Follow Up (Up to 18 months)Population: This questionnaire was added as an amendment after the majority of patients had been enrolled and assessed. Once the amendment was Emory IRB approved, the questionnaire was administered to the remaining 31 patients.
Participants will be asked to rate how different the look of their radiated breast is compared to their non-radiated breast on a study specific scale from 0 to 10 where 0 represents no difference, and 10 represents completely different.
Outcome measures
| Measure |
Participants With Stage 0-III Breast Cancer
n=31 Participants
Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.
Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
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|---|---|
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Change in Radiated Breast Appearance Score
|
-0.81 score on a scale
Standard Deviation 4.02
|
Adverse Events
Participants With Stage 0-III Breast Cancer
Serious adverse events
| Measure |
Participants With Stage 0-III Breast Cancer
n=74 participants at risk
Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.
Hypofractionated Simultaneous Integrated Boost Radiotherapy: Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
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|---|---|
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Recurrance
|
4.1%
3/74 • Number of events 3 • 60 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place